BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 2-LUMEN 8 FR X 20 CM

    MDR report key: 7309752 · Received March 2, 2018

    Report

    Report Number
    1036844-2018-00091
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    February 13, 2018
    Report Date
    March 2, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED AN OPENED CS-25802-E KIT CONTAINING A GUIDE WIRE ASSEMBLY, ARS AND INTRODUCER NEEDLE FOR EVALUATION. THE INTRODUCER NEEDLE WAS RETURNED ATTACHED TO THE ARS AND THE DISTAL END OF THE GUIDE WIRE WAS ADVANCED THROUGH THE ARS/NEEDLE ASSEMBLY. THE PROXIMAL END OF THE GUIDE WIRE WAS RETRACTED WITHIN THE ADVANCER ASSEMBLY. THE COMPONENTS SHOWED EVIDENCE OF USE AND NO OTHER COMPONENTS WERE RETURNED. THE GUIDE WIRE WAS ABLE TO BE REMOVED FROM THE ARS/NEEDLE ASSEMBLY DURING DECONTAMINATION. VISUAL EXAMINATION OF THE GUIDE WIRE REVEALED THAT IT WAS KINKED IN SEVERAL LOCATIONS ALONG THE BODY. WITH THE NAKED EYE, THE DISTAL J-BEND APPEARED TO BE DEFORMED BUT INTACT; HOWEVER, MICROSCOPIC EXAMINATION REVEALED THAT THE DISTAL WELD WAS NOT PRESENT AT THE DISTAL END OF THE GUIDE WIRE. THE DISTAL WELD HAD SEPARATED FROM BOTH THE COIL WIRE AND THE CORE WIRE AND WAS NOT RETURNED. BECAUSE THE WELD WAS SEPARATED, THE GUIDE WIRE WAS ABLE TO BE UNRAVELED FROM THE DISTAL END. THE DISTAL END OF THE CORE WIRE WAS EXPOSED AND THE CORE WIRE RETAINED IT J-SHAPE INDICATING IT HAD BROKEN ADJACENT TO THE WELD. THE SEPARATION POINT OF THE DISTAL END OF THE CORE WIRE WAS NOT TAPERED BUT WAS SLIGHTLY DISCOLORED. THE PROXIMAL WELD WAS FULL AND SPHERICAL. VISUAL EXAMINATION OF THE INTRODUCER NEEDLE AND THE ARS REVEALED EVIDENCE OF USE (DRIED BLOOD) BUT NO DEFECTS OR ANOMALIES. THE KINKS IN THE GUIDE WIRE BODY WERE MEASURED AT 344, 375 AND 578 MM FROM THE PROXIMAL TIP. THE BROKEN CORE WIRE MEASURED 602 MM IN LENGTH, WHICH IS WITHIN SPECIFICATION; THEREFORE IT APPEARS THE CORE WIRE BROKE DIRECTLY ADJACENT TO THE DISTAL WELD. THE OUTSIDE DIAMETER OF THE GUIDE WIRE AND THE NEEDLE CANNULA INNER DIAMETER WERE MEASURED AND BOTH WERE FOUND TO BE WITHIN SPECIFICATION. THE UNDAMAGED PROXIMAL END OF THE GUIDE WIRE WAS ADVANCED THROUGH THE ARS AND INTRODUCER NEEDLE TO FUNCTIONALLY TEST THE COMPONENTS. THE GUIDE WIRE PASSED THROUGH BOTH COMPONENTS WITH MINIMAL RESISTANCE. A LAB INVENTORY GUIDE WIRE OF SAME DIAMETER AS THAT SUPPLIED IN KIT CS-25802-E PASSED THROUGH THE RETURNED ARS AND INTRODUCER NEEDLE WITH MINIMAL RESISTANCE. A MANUAL TUG TEST CONFIRMED THAT THE PROXIMAL WELD WAS INTACT. THE RETURNED INTRODUCER NEEDLE HUB ATTACHES TO THE ARS MALE LUER TAPER AS EXPECTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE GUIDE WIRE, ARS AND INTRODUCER NEEDLE AND NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. THE INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THE KIT DESCRIBES SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF GUIDE WIRE DAMAGE DURING USE. THE INSTRUCTIONS CAUTION THAT WITHDRAWING THE GUIDE WIRE AGAINST THE NEEDLE BEVEL OR USE OF EXCESSIVE FORCE DURING REMOVAL COULD DAMAGE OR BREAK THE WIRE. THE REPORT THAT THE GUIDE WIRE WAS DAMAGED/SEPARATED WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. THE CORE WIRE WAS BROKEN ADJACENT TO THE DISTAL WELD WHICH HAD SEPARATED FROM THE CORE WIRE AND COIL WIRE. THE GUIDE WIRE, ARS AND INTRODUCER NEEDLE MET ALL FUNCTIONAL/DIMENSIONAL REQUIREMENTS DURING INVESTIGATION TESTING. NO MANUFACTURING DEFECTS WERE FOUND DURING THIS INVESTIGATION. ARROW GUIDE WIRES OF THIS SIZE ARE DESIGNED AND MANUFACTURED TO WITHSTAND A TENSILE FORCE OF 2.75 POUNDS FORCE. THIS INTERNAL SPECIFICATION IS HIGHER THAN THE BS EN ISO 11070:2014 STANDARD OF 2.2 POUNDS FORCE FOR THIS SIZE WIRE. THE SELECTED INSERTION SITE AND PATIENT ANATOMY MAY PRESENT A TORTUOUS PATH THAT COULD CONTRIBUTE TO THE POSSIBILITY OF GUIDE WIRE KINKING. GUIDE WIRE BREAKAGE MAY OCCUR IF A FORCE GREATER THAN THE DESIGN SPECIFICATION IS APPLIED DURING REMOVAL. BASED ON THESE CIRCUMSTANCES, IT WAS DETERMINED THAT OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGES THE SWG (SPRING WIRE GUIDE) COULDN'T BE ADVANCED THROUGH THE ARS (SYRINGE).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRELIMINARY EVALUATION OF THE RETURNED DEVICE SAMPLE INDICATES SWG/ARS RESISTANCE - KINKED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THE SWG (SPRING WIRE GUIDE) COULDN'T BE ADVANCED THROUGH THE ARS (SYRINGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152461 ARROW CVC SET: 2-LUMEN 8 FR X 20 CM CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL INC. 23F17F0591

    Patients

    Seq Age Sex Outcome Treatment
    1